Moffitt logo

COVID-19 Update: See the latest on our visitor policy here. Learn More

Clinical Trials Search

Clinical Trial 20854

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT05358938

Phase: N/A
Principal Investigator: Kanetsky, Peter

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Summary

Investigators will obtain preliminary data on an exercise intervention in participants who are receiving checkpoint blockade immunotherapy. Exercise is completed on the same day of immunotherapy infusion. Information collected during this study will inform how exercise may impact immunological biomarkers and disease outcome.

Objective

This pilot study will provide i) information on the feasibility of implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention. Aim 1. To determine the acceptability of the exercise intervention and feasibility of patients to complete 20-30 minutes of supervised moderate exercise on the same day as receiving checkpoint blockade immunotherapy. Aim 2. To estimate the impact of exercise on tumor immunological biomarkers and disease outcome.

Treatments

Therapies

Medications

Inclusion Criteria

  • Age >18 years
  • Able to read and speak English fluently
  • Capable of giving informed consent
  • Patient has received a complete COVID-19 vaccination series.
  • Reported ability to complete 20-30 minutes moderate exercise per positive response on the six-minute walk test
  • Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy)
  • Melanoma patients (adjuvant setting)
  • Melanoma patients (neoadjuvant setting)
  • cuSCC patients (neoadjuvant setting)
  • Merkel cell carcinoma patients (neoadjuvant setting)

  • Exclusion Criteria

  • Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
  • Presence of major postoperative complications for which an exercise intervention may not be warranted.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.